Tranexamic Acid for Surgical Bleeding Control

Recruiting in Palo Alto (17 mi)

Overseen byBrian Kinard, DMD, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?This prospective study will analyze the need for deliberate hypotensive anesthesia (DHA) during orthognathic surgery when tranexamic acid (TXA) is administered. DHA has been proven to be effective although it comes with multiple risks related to organ hypoperfusion including kidney injury, stroke, and cardiac ischemia. Therefore, it may be potentially safer for patients to avoid deliberate hypotensive anesthesia if TXA alone adequately controls blood loss and provides adequate surgical site visualization.

Eligibility Criteria

This trial is for individuals undergoing bimaxillary orthognathic surgery at UAB Highlands Hospital. It's not suitable for those with high blood pressure, heart issues, bleeding disorders, or who can't safely receive tranexamic acid (TXA).

Inclusion Criteria

I had jaw surgery at UAB Highlands Hospital.

Exclusion Criteria

I have a bleeding disorder.

I have a history of high blood pressure or heart issues.

I cannot take TXA due to medical reasons.

Participant Groups

The study is testing if using TXA during jaw surgery can control blood loss well enough to avoid the need for deliberately lowering blood pressure—anesthesia practice that reduces bleeding but has risks like kidney and heart problems.

1Treatment groups

Experimental Treatment

Group I: Patients Receiving Tranexamic Acid with Avoidance of Hypotensive AnesthesiaExperimental Treatment2 Interventions

Tranexamic Acid is already approved in United States, European Union, Canada, Japan, Australia for the following indications:

🇺🇸 Approved in United States as Tranexamic Acid for: